ISO 15189: 2022 is the standard for quality and competence in medical laboratories, now incorporating the Point of Care Testing (POCT) requirements formerly covered by ISO 22870. Applying the requirements of this revised standard will ensure that you plan and implement an effective and patient-focused management system, where addressing risks and opportunities for improvement is central to everything that you do.    

The new version of the standard is much less prescriptive than the 2012 version, meaning you can benefit from increased flexibility in exactly how you meet those requirements. There is, however, a trade-off in understanding and demonstrating what is appropriate for the service you provide, and what is not. A key emphasis is the application of risk-based thinking – common across all ISO management standards – how you use it, what factors are considered and how the risks and opportunities identified can be addressed to benefit the patient.  

Whether you are setting out for the first time with the standard, or need to transition to the latest version, we can work with you to navigate the detailed requirements. We can help you to ensure that the standard works effectively for your organisation, provides confidence that your medical laboratory can deliver high levels of performance and competence. 

Do you operate a medical laboratory? Are you committed to patient care? Of course you are.  

The standard is intended for use by a wide variety of medical laboratory disciplines, including (but not limited to) microbiology, haematology, clinical biochemistry, immunology, and genetics. But it can also be applied to other services relating to health diagnostics and therapy such as imaging, physiological sciences, and transfusion services. The world is your petri-dish.  

This new revision of ISO 15189 aligns with best practice principles for risk management and laboratory safety as well as the core disciplines which are central to effective medical laboratory management. If you are looking to demonstrate the quality and competence of your medical laboratory, to promote the welfare of patients, and to secure the benefits of an effective and robust management system then ISO 15189 is relevant to you.  

The latest revision of this ISO standard was released in December 2022. It underlines the importance of continually improving quality standards relating to medical laboratories and focuses on better understanding - and addressing - the risks of the services provided to the patient. If you are already certified to the 2012 version of the standard, the new requirements will build upon much of what you have in place, but a programme of work will be needed to address the changes in a timely manner to meet the transition requirements and successfully gain certification to the new revision.  

Whether you are transitioning from the earlier edition of the standard - or are just starting out with it - QFactorial can support you to establish a compliant system, maximise the benefit to you and to patients, and to help you towards your accreditation.   

We are, first and foremost, a quality management consultancy. And we are really keen on the consulting part. By engaging with us you can be assured we will listen carefully to your story and understand the details of what you want, and what you need (which are not always the same thing!). Our consultants can then offer you a uniquely tailored solution. We're Quality People, and we understand how to bend and shape the ISO framework to add value to your business.  

After the revision, the standard now more closely follows the format of ISO 17025 and better aligns with ISO 9001. It also contains the additional requirements for Point of Care Testing (POCT) which have been brought over from the now defunct ISO 22870.  

The new revision focuses on building, maintaining, and improving confidence in the quality and competence of medical laboratories - particularly through the application of robust risk analysis and mitigation - to promote the welfare of patients.  

For those of you already accredited to the 2012 version of this standard, or to the old ISO 22780 POCT standard, the clock is ticking, and your three-year transitional countdown has begun. All organisations will need to be reassessed to the 2022 revision by December 2025 if they want to keep their accredited status. QFactorial can help your business to make the required transition effectively, and if you are starting out for the first time, we can support you in using this standard to establish a robust and effective system and work towards your accreditation. 

The standard sets out key requirements for quality and competence linked to the structure and governance of the medical laboratory, including the responsibilities of the laboratory director, and for planning and implementing actions to tackle risks and opportunities. It addresses resources in terms of personnel, equipment, reagents and consumables and establishes the controls required for service agreements and externally provided content. It also sets out in detail the process requirements for examination and incorporates the pre- and post- examination controls supporting the handling of samples and reporting of results.   

The standard incorporates arrangements for examination requests, patient preparation, patient identification, collection of samples, transportation, processing of clinical samples, selection of examinations that are fit for intended use, examination of samples, and sample storage. Laboratories are also responsible for subsequent interpretation, reporting and advice to users, which may include providing results to patients, providing urgent testing and the notification of critical results.  

Requirements for the secure control of data and information management are set out, including plans in case of IT system failures and controls for externally provided IT providers. Also included are requirements for effective handling of nonconforming work and complaints, and for overall contingency planning and emergency preparedness. 

At the heart there is a need to establish and maintain a documented and effective management system which includes clearly understood and implemented objectives and policies. In addition to requirements for the control of documents and records there is a strong focus on actions to address risks and opportunities for improvement, including effectively addressing feedback and nonconformities, and for having a strong process for evaluation of the whole system – including the use of quality performance indicators, internal audits and management reviews.   

Overall, the standard provides the basis for increasing the effectiveness of the management system for medical laboratories in recognition that they are an essential factor in patient care. With our extensive knowledge of the standard and an eye to the specific needs and benefits for your business we can support you to build and maintain a robust, effective, and compliant system for your medical laboratory. 

Whatever stage you are at we can help you. Whether you are just starting your laboratory or have an established facility - or facilities - already certified as ISO 9001, or maybe you are working towards your ISO 15189 accreditation or even have it in place but feel it needs to be more effective. 

The first step towards achieving compliance – wherever you are on your journey – is to identify any gaps between the policies, processes, and procedures you currently have in place compared to the requirements of ISO 15189, and to develop an action plan for implementing any new or amended requirements. We can support you, focusing on what you currently have, what can be adapted or improved, what you may need to add or change, and what you will need to document. With our extensive knowledge and experience we can help you to develop and improve your processes so that your system not only gets you through the USAS assessment, but also becomes an effective tool for continuous improvement. 

In the UK the accreditation process for ISO 15189 is administered by UKAS, the UK’s National Accreditation Body for certification, calibration, inspection, and testing services. UKAS accreditation is recognised by government, industrial and academic organisations, who require confidence in their choice of testing or calibration laboratory.  

The stages in the accreditation process include a gap analysis submitted to UKAS (with evidence), gap closure, on-site/remote assessment by UKAS, corrective action, recommendation and accreditation.  

QFactorial can help you to document your system, improve your processes, audit those processes, fix any problems, train your people. We can help you compile your initial UKAS application, carry out the gap analysis, and support you through all the stages through to successful accreditation – and beyond.   

Anything worth having is going to involve some work. Getting accredited to ISO 15189 by UKAS needs planning, commitment and resources.  The amount of work involved will depend on factors such as your current stage of development, the size of your organisation, the number of facilities and the number of people in your team. We will work closely with you to identify your gaps and synergies against the requirements of the standard, and to develop a practical action plan to achieve your accreditation in the most efficient way. Our effective project management and extensive know-how will support your schedule and budget with resources tailored to help you at every stage. 

Whether you are starting from scratch, building on a foundation of ISO 9001, or migrating from the 2012 version of the standard (including POCT moving from ISO 22870), there are requirements to define and maintain your policies, processes, procedures and records. You will need to document roles and responsibilities of personnel and demonstrate the competence, continuing education, and professional development of your staff. You will need to be able to evidence how your system meets the requirements of each of the clauses in a clear and consistent way. And you will need to consider in detail the identification of risks and opportunities for improvement, the actions to be taken, as well as corrective actions, internal audits, management review and continual improvement. 

The key is to maintain sufficient documentation to demonstrate the effectiveness of your management system, how you actually do things, what processes you use, who is involved and how you record your results. QFactorial can help you to design, document, implement and manage your ISO 17025 system to support your journey to accreditation - so that it meets the requirements of the standard and works for your business. 

How long is a piece of string? 

You’re not a cookie-cutter company, so we don’t deal with cookie-cutter prices. But let’s talk about what makes up the cost of UKAS accreditation: 

• Finding out where you’re starting from, where you need to be and how to get there. (GSAAP). 

• In house resources to manage and deliver the work plan. 

• External consultants to help with parts of the plan that are outside your skills and experience (or time). 

• UKAS fees. 

• Maintenance of your accreditation. Not just polishing the frame. 

Depending on the size, scale and complexity of your organisation, you may need more or less consultancy time. We can work with you based on a specific number of days at an agreed rate; carefully scoped, fixed price work packages; or a combination of both to suit your budget. 

Laboratory approvals are different to most ISO management system approvals in that they involve direct accreditation rather than certification by an accredited certification body. In the UK the accreditation process for laboratories is administered and delivered directly by UKAS, the UK’s National Accreditation Body for certification, calibration, inspection, and testing services.  

This means that the task of selecting a certification body is not required because you will be dealing directly with UKAS, so it’s more about appointing than selecting.  

We’ve been in this game a long time now and have developed a proven system of tackling the requirements of ISO accreditation with you. We begin with our Gap & Synergy Assessment with Action Plan (GSAAP for those acronym lovers) which shows us how close you already are to the standard requirements. We find, usually, that there are many more synergies than you’d expect - you’re running a successful business after all, aren’t you? 

This gives us a head-start when creating the management system and gives you the opportunity to get to know your consultant and confirm you enjoy working with us before embarking on the good ship accreditation. At this point you’re able to take the GSAAP and run, but of course we’d like to think you’d want to keep working with us to help you with the application, documentation and implementation.  

We help share the load by reviewing what you create, or creating things for your review – quality/laboratory manuals, process maps, policies, SOPs etc. Once this is all done, there’s a desktop audit by UKAS to check all your documentation complies with the rigours of your chosen standard - and yes, we can be involved in this as your advocate, interpreter, translator or referee. This stage is all about ‘saying what you do’ as a business. But you can’t just say what you do, you also need to ‘do what you say’. The next stage is all about those documents coming off the page and becoming a ‘real’ entity in your business. The burden of proof is on you to show that your system, as you’ve set out in your quality/laboratory manual, is working as you say it should be. It takes time to gather this body of evidence, anywhere from 3-6 months, and this evidence can take various forms. Our role during this stage is to provide training, mentoring, internal audits and management reviews to ensure your business is ready for the final audit. It’s entirely normal for a few ‘nonconformities’ to arise, especially at this stage, but we’ll be there to help you deal with them and make sure you get that recommendation for accreditation. 

At this point you’re able to take your new ISO certificate, pat yourselves on the back for a job well done and send us on our merry way, happiness all round. However, we recommend you stick with us for the first few months. Why? So we can help establish quarterly health checks to keep things ticking over. Unlike most ISO approvals where the first surveillance audit is 11 months in the future, UKAS will return after 6 months to re-audit and check that you are still implementing your system and compliant with the standard. You don’t want to be thrown into a full-blown panic as the surveillance visit looms and you realise things have gotten a little wobbly. With us on board that little while longer, you can be sure that the gears are turning and the processes are followed so when the auditor returns, you’re armed and, if not dangerous, at least prepared.